Comprehensive specialty care versus usual community care for first-episode psychosis: 2-year outcomes from the NIMH RAISE Early Treatment Program
John M. Kane, M.D.
The National Institute of Mental Health (NIMH) issued a Request for Proposals entitled “Recovery After an Initial Schizophrenia Episode (RAISE)” in November 2008. The goal of the NIMH initiative is to change the trajectory and prognosis of first episode psychosis (FEP). The premise is that by combining state-of-the-art pharmacologic and psychosocial treatments in a patient-centric fashion and having them delivered by a well-trained and coordinated, multidisciplinary team, the functional outcome and quality of life for first episode patients treated in the community can be significantly improved. The specified aims of RAISE are, first, to develop a comprehensive and integrated intervention designed to: promote symptomatic recovery; minimize disability; maximize social academic and vocational functioning; be capable of being delivered in real world settings utilizing current funding mechanisms, and, second, to assess the overall clinical impact and cost effectiveness of the intervention as compared to currently prevailing treatment approaches and to conduct the comparison in non-academic, real world community treatment settings in the U.S
We developed a treatment model (NAVIGATE) and training program based on extensive literature review and expert consultation. Our primary aim is to compare the experimental intervention to “usual care” on quality of life. Secondary aims include comparisons on remission, recovery and cost effectiveness. Patients 15-40 years old with a first episode of schizophrenia; schizoaffective disorder; schizophreniform disorder, psychotic disorder NOS, or brief psychotic disorder according to DSM IV and no more than six months of antipsychotic medications were eligible. Patients are followed for a minimum of two years, with major assessments conducted by blinded, centralized raters using live, two-way video. We selected 34 clinical sites in 21 states and utilized cluster randomization to assign 17 to the experimental treatment-NAVIGATE and 17 to usual care. Enrollment began in July 2010 and ended in July 2012 with 404 subjects.
Four hundred and four individuals participated in the controlled trial. The mean age was 23. The median duration of untreated psychosis was 74 weeks. Those patients who received the comprehensive care intervention –NAVIGATE- were more likely to stay in treatment, had significantly greater improvement in quality of life, psychopathology and participation in work or school. Duration of untreated psychosis was a significant mediator